FinWise Bancorp to Report Third Quarter 2022 Results on Wednesday, October 26, 2022

MURRAY, Utah, Sept. 29, 2022 (GLOBE NEWSWIRE) — FinWise Bancorp (NASDAQ: FINW) (“FinWise” or the “Company”), the parent company of FinWise Bank, announced today that it will report its third quarter 2022 results and host a call after the market close on Wednesday, October 26, 2022.

A webcast will be available on the Company’s website at FinWise Earnings Call Live Webcast.

The Company will also hold a conference call to discuss results at 5:30 PM ET on that day. The dial-in number for the conference call is 1-877-423-9813 (toll-free) or 1-201-689-8573 (international). Please dial the number 10 minutes prior to the scheduled start time.

A webcast replay of the call will be available at Investor Relations | FinWise Bancorp (gcs-web.com) for six months following the call.  

About FinWise Bancorp

FinWise Bancorp is a Utah bank holding company headquartered in Murray, Utah. FinWise operates through its wholly-owned subsidiary, FinWise Bank, a Utah state-chartered non-member bank. FinWise currently operates one full-service banking location in Sandy, Utah. FinWise is a nationwide lender to and takes deposits from consumers and small businesses. Learn more at www.finwisebank.com.

Contacts:

[email protected]

[email protected]        



Applied Blockchain Sets Fiscal First Quarter 2023 Earnings Conference Call for Tuesday, October 11, 2022 at 5:00 p.m. Eastern Time

DALLAS, Sept. 29, 2022 (GLOBE NEWSWIRE) — Applied Blockchain, Inc. (Nasdaq: APLD)(“Applied Blockchain” or the “Company”), a designer, builder and operator of next-generation datacenters that provide power to blockchain infrastructure and support High-Performance Computing (HPC) applications, will host a conference call on Tuesday, October 11, 2022 at 5:00 p.m. Eastern Time to discuss its operations and financial results from the fiscal first quarter ended August 31, 2022. A press release detailing these results will be issued after the close of trading on the same day.

Applied Blockchain management will provide prepared remarks, followed by a question-and-answer period.

Date: Tuesday, October 11, 2022
Time: 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time)
U.S. dial-in number: 1-877-407-0792
International number: 1-201-689-8263
Conference ID: 13733281

The conference call will broadcast live and be available for replay here.

Please call the conference telephone number approximately 10 minutes before the start time. An operator will register your name and organization. If you have any difficulty connecting with the conference call, please contact Applied Blockchain’s investor relations team at 1-949-574-3860.

A replay of the call will be available after 8:00 p.m. Eastern Time October 11, 2022 through October 25, 2022.

Toll-free replay number: 1-844-512-2921
International replay number: 1-412-317-6671
Conference ID: 13733281

About Applied Blockchain

Applied Blockchain, Inc. (Nasdaq: APLD) designs, develops and operates next-generation datacenters across North America to provide low-cost digital infrastructure solutions to the rapidly growing high performance computing (HPC) industry. The Company has partnered with the most recognized names in the industry to develop, deploy, and scale its business. Find more information at www.appliedblockchaininc.com. Follow us on Twitter at @APLDBlockchain.

Investor Relations Contacts

Matt Glover or Jeff Grampp, CFA
Gateway Group, Inc.
(949) 574-3860
[email protected]

Media Contact

Brenlyn Motlagh
Gateway Group, Inc.
(949) 899-3135
[email protected]



Zscaler Acquires ShiftRight to Integrate Security Workflow Automation Technology into the Zero Trust Exchange Platform

ShiftRight’s Security Workflow Automation Strengthens Zscaler’s Cloud Security Platform by Simplifying Security Operations and Enabling Visibility into Security Posture

SAN JOSE, Calif., Sept. 29, 2022 (GLOBE NEWSWIRE) — Zscaler, Inc. (NASDAQ: ZS), the leader in cloud security, today announced it has completed its acquisition of ShiftRight, a leader in closed loop security workflow automation. ShiftRight’s workflow automation technology is currently being integrated into the Zscaler Zero Trust Exchange™ cloud security platform to automate security management for the growing influx of risks and incidents organizations are experiencing. This integration will provide a simple, sophisticated solution to reduce incident resolution time dramatically.

“I am excited to welcome the ShiftRight team into the Zscaler family,” said Jay Chaudhry, CEO, chairman and founder of Zscaler. “The decision to acquire ShiftRight was the logical next step because we saw the immense benefits of their technology during our pre-existing technology partnership. We will now extend the value of Zscaler’s platform with ShiftRight by simplifying IT and security operations through security workflow automation. The integration of ShiftRight’s technology into Zscaler’s cloud platform will help customers establish clear lines of responsibility and provide real-time visibility for their security posture.”

Security teams are held accountable, but are not directly responsible, for many security-related actions. This misalignment has become a source of contention for organizations as the security landscape becomes crowded, fragmented and complex. In practice, the responsibility for cybersecurity is distributed throughout multiple teams in an organization. Security teams are forced to work with multiple distinct groups to keep users and data properly secured. The current working model is an ineffective patchwork of error-prone spreadsheets interlaced with disparate systems where critical security issues fall through the cracks.

“ShiftRight is a natural fit for the Zscaler Zero Trust Exchange by automating accountability and responsibility management for security teams,” said Sanjay Kalra, CEO of ShiftRight (now a part of Zscaler). “As an integrated capability into Zscaler’s platform, ShiftRight’s technology will strengthen Zscaler’s offerings and transform security into a collaborative solution for internal teams to tackle numerous security challenges, like remediation, deployment, compliance and upgrades.”

The transaction closed in Zscaler’s fiscal fourth quarter ended July 31, 2022. Terms of the transaction were not disclosed.

Forward-Looking Statements

This press release contains forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. These forward-looking statements include the expected benefits of the acquisition to Zscaler’s product offerings and to our customers. These forward-looking statements are subject to the safe harbor provisions created by the Private Securities Litigation Reform Act of 1995. A significant number of factors could cause actual results to differ materially from statements made in this press release, including those factors related to our ability to successfully integrate ShiftRight technology into our cloud platform and our ability to retain key employees of ShiftRight after the acquisition.

Additional risks and uncertainties are set forth in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on September 15, 2022, which is available on our website at ir.zscaler.com and on the SEC’s website at www.sec.gov. Any forward-looking statements in this release are based on the limited information currently available to Zscaler as of the date hereof, which is subject to change, and Zscaler will not necessarily update the information, even if new information becomes available in the future.

About Zscaler

Zscaler (NASDAQ: ZS) accelerates digital transformation so customers can be more agile, efficient, resilient, and secure. The Zscaler Zero Trust Exchange protects thousands of customers from cyberattacks and data loss by securely connecting users, devices, and applications in any location. Distributed across more than 150 data centers globally, the SSE-based Zero Trust Exchange is the world’s largest in-line cloud security platform.

Zscaler™ and the other trademarks listed at


https://www.zscaler.com/legal/trademarks


are either (i) registered trademarks or service marks or (ii) trademarks or service marks of Zscaler, Inc. in the United States and/or other countries. Any other trademarks are the properties of their respective owners.

Media Contact:

Natalia Wodecki
[email protected]

Investor Relations Contact:

Bill Choi, CFA
[email protected]



Selecta Biosciences Board Member, Timothy Springer, Ph.D., Wins Lasker Award for Seminal Discovery of Key Adhesion Molecules that Mediate Immune Cell Interactions

WATERTOWN, Mass., Sept. 29, 2022 (GLOBE NEWSWIRE) — Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company pioneering precision immune tolerance with its clinically validated ImmTOR® platform to develop tolerogenic therapies for autoimmune diseases, unlock the potential of gene therapies and amplify the efficacy of biologic therapies, extends its congratulations to its board of directors member, Timothy Springer, Ph.D., who yesterday won the Albert Lasker Basic Medical Research Award for his seminal discovery of integrin adhesion molecules that regulate trafficking, cell-cell interactions, and effector functions of lymphocytes and other immune cells. The leukocyte integrins were found to be part of a larger family of integrins involved in fundamental cell interactions related to embryonic development, hemostasis and other processes and discovered by Lasker Award co-winners Dr. Richard Hynes and Dr. Erkki Rouslahti. Selecta’s Chief Scientific Officer, Kei Kishimoto, Ph.D., was a key contributor to this foundational work during his time in Dr. Springer’s lab.

“Tim’s contributions to the field of immunology are truly monumental,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Selecta Biosciences. “Our increased understanding of the principles governing complex immune cell interactions have opened vast opportunities for therapeutic development, and Selecta continues to benefit tremendously from Tim’s scientific insights and advice.”

The Lasker Awards program was created to highlight fundamental biological discoveries and clinical advances that improve human health, and to draw attention to the importance of public support of science.

About Selecta Biosciences, Inc.

Selecta Biosciences Inc. (NASDAQ: SELB) is a clinical stage biotechnology company leveraging its ImmTOR® platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses. With a proven ability to induce tolerance to highly immunogenic proteins, ImmTOR has the potential to amplify the efficacy of biologic therapies, including redosing of life-saving gene therapies, as well as restore the body’s natural self-tolerance in autoimmune diseases. Selecta has several proprietary and partnered programs in its pipeline focused on enzyme therapies, gene therapies, and autoimmune diseases. Selecta Biosciences is headquartered in the Greater Boston area. For more information, please visit www.selectabio.com.

Selecta Forward-Looking Statements

Any statements in this press release about the future expectations, plans and prospects of Selecta Biosciences, Inc. (the “Company”), including without limitation, statements regarding the unique proprietary technology platform of the Company, and the unique proprietary platform of its partners, the potential of ImmTOR to enable re-dosing of AAV gene therapy and to mitigate immunogenicity, the potential of ImmTOR and the Company’s product pipeline to treat chronic refractory gout, MMA, IgAN, other autoimmune diseases, lysosomal storage disorders, or any other disease, the anticipated timing or the outcome of ongoing and planned clinical trials, studies and data readouts, the anticipated timing or the outcome of the FDA’s review of the Company’s regulatory filings, the Company’s and its partners’ ability to conduct its and their clinical trials and preclinical studies, the timing or making of any regulatory filings, the potential treatment applications of product candidates utilizing the ImmTOR platform in areas such as gene therapy, gout and autoimmune disease, the ability of the Company and its partners where applicable to develop gene therapy products using ImmTOR, the novelty of treatment paradigms that the Company is able to develop, whether the observations made in non-human study subjects will translate to studies performed with human beings, the potential of any therapies developed by the Company to fulfill unmet medical needs, the Company’s plan to apply its ImmTOR technology platform to a range of biologics for rare and orphan genetic diseases, the potential of the Company’s technology to enable repeat administration in gene therapy product candidates and products, the ability to re-dose patients and the potential of ImmTOR to allow for re-dosing, the potential to safely re-dose AAV, the ability to restore transgene expression, the potential of the ImmTOR technology platform generally and the Company’s ability to grow its strategic partnerships, enrollment in the Company’s clinical trials and the Company’s plans with respect to areas affected by geopolitical conflict and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hypothesize,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, but not limited to, the following: the uncertainties inherent in the initiation, completion and cost of clinical trials including proof of concept trials, including the uncertain outcomes, the availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a particular clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, the ability to predict results of studies performed on human beings based on results of studies performed on non-human subjects, the unproven approach of the Company’s ImmTOR technology, potential delays in enrollment of patients, undesirable side effects of the Company’s product candidates, its reliance on third parties to manufacture its product candidates and to conduct its clinical trials, the Company’s inability to maintain its existing or future collaborations, licenses or contractual relationships, its inability to protect its proprietary technology and intellectual property, potential delays in regulatory approvals, the availability of funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements, the Company’s recurring losses from operations and negative cash flows, substantial fluctuation in the price of its common stock, risks related to geopolitical conflicts and pandemics and other important factors discussed in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K, as supplemented by subsequent Quarterly Reports on Form 10-Q, and in other filings that the Company makes with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. The Company specifically disclaims any intention to update any forward-looking statements included in this press release except as required by law.

For investors:

Bruce Mackle
LifeSci Advisors, LLC
+1-929-469-3859
[email protected]

For media: 

Brittany Leigh, Ph.D.
LifeSci Communications, LLC
+1-813-767-7801
[email protected] 



Coursera Launches Expanded Clips Offering with Nearly 200K Short Videos and Lessons to Accelerate Skills Development for Employees

Coursera Launches Expanded Clips Offering with Nearly 200K Short Videos and Lessons to Accelerate Skills Development for Employees

Enables microlearning to develop high-demand skills fast; increases leadership content by 10x

MOUNTAIN VIEW, Calif.–(BUSINESS WIRE)–
Coursera, Inc. (NYSE: COUR) today announced the expansion of Clips, which now provides employees access to nearly 200,000 short videos and lessons designed to help them begin learning high-demand skills in under 10 minutes.

“Lack of career development is a key reason many employees leave an organization. Yet employees have less time to devote to learning than ever before,” said Leah Belsky, Chief Enterprise Officer at Coursera. “A growing number of employees are now looking to gain job-specific skills much faster through shorter, more targeted content. With this shift towards microlearning, Clips enables employees to learn specific skills with 5-10 min videos. It also provides clear pathways into courses for deeper skill development, while driving continuous learning to ensure employees have the right skills to accelerate company growth and innovation.”

The initial Clips on Coursera offering featured bite-sized videos focused on business, tech, data, leadership, and human skills. The expanded Clips offering now provides a more comprehensive library of content, including a higher volume of videos for skills that are becoming increasingly more important like leadership and management. Currently, 83 percent of businesses feel it is important to develop leaders at all levels. Yet less than 5 percent have actually implemented leadership training across every level within their organization. To help address this growing need, Coursera has increased the number of leadership and management-related Clips by 10x.

As learners quickly gain skills through Clips, many then seek opportunities for deeper development. Thirty-six percent of learners that have viewed Clips to address their in-the-moment learning needs have gone on to enroll in at least one course1.

The most viewed Clips to date include a range of data, cloud, and productivity-focused content such as:

  • Welcome to Python, by University of Michigan [1 min]
  • Fundamentals of Data Science, by IBM [2 min]
  • The Business Case for Visionary Leadership, by University of Michigan [7 min]
  • Why is Storytelling Important?, by Macquarie University [9 min]
  • Key Cloud Service Providers and their Services, by IBM [6 min]
  • What is SQL Anyway?, by University of California, Davis [7 min]
  • Customize Google Calendar, by Google [4 min]
  • Taking Charge of Excel, by Macquarie University [6 min]

Global industry leaders and government organizations like Google, New York State Department of Labor, Alstom, and Bosch have adopted Clips to help accelerate skills development within their workforce. Google in particular has made Clips available to all employees worldwide, helping many learners obtain skills that will help them elevate their job performance and begin unlocking new advancement opportunities.

With Clips, Coursera now offers fully scalable learning paths featuring everything from short videos and lessons to professional certificates, and degree programs.

“For my role, developing skills in programming, camera hardware, and design is crucial. Finding relevant courses to acquire these new skills, and gaining practical, hands-on experience has been a challenge,” said Doris Chen, hardware design engineer at Google. “The Clips videos provide relevant content focused on everything from camera and imaging to optical system design. As I continue my training, I’m looking forward to enrolling in more advanced classes and potentially earning an additional degree online to help further my career.”

“I have always been fascinated by the concept of skills development programs and self-paced learning, and the ways it can assist to level up your career,” said Rajat Batra, software engineer at Google. “Clips takes this concept to the next level by adding short and focused job related videos. These videos act as a good starting point to develop a higher level of understanding for several concepts.”

Coursera for Business now enables over 3,500 companies across the globe to deploy world-class skills development content from top businesses and universities. The company’s skills platform gives organizations the ability to assess, measure, and benchmark skills in their workforce. Recent platform innovations including LevelSets are helping employees to quickly determine their proficiency in key skills and identify areas to focus on moving forward. In addition, SkillSets help employees develop specific skills for specific roles. These Skill Sets provide the foundation for Coursera’s Leadership and Data & Analytics Academies, which offer a packaged learning experience based on the depth of skill needed for specific roles across an organization.

For additional information on Clips, visit here.

About Coursera

Coursera (NYSE: COUR) was launched in 2012 by two Stanford Computer Science professors, Andrew Ng and Daphne Koller, with a mission to provide universal access to world-class learning. It is now one of the largest online learning platforms in the world, with 107 million registered learners as of June 30, 2022. Coursera partners with over 275 leading university and industry partners to offer a broad catalog of content and credentials, including Guided Projects, courses, Specializations, certificates, and bachelor’s and master’s degrees. Institutions around the world use Coursera to upskill and reskill their employees, citizens, and students in many high-demand fields, including data science, technology, and business.

1 Coursera customer analytics data, Sept. 2022

Media Contact:

Brandon Brunson

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Professional Services Continuing Training Human Resources Education

MEDIA:

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Businesses Can Reduce Risk and Optimize Commerce with New Data-as-a-Service Through Carat from Fiserv

Businesses Can Reduce Risk and Optimize Commerce with New Data-as-a-Service Through Carat from Fiserv

Ability to access transactional data via the Snowflake Data Cloud will enable near-real-time data intelligence

BROOKFIELD, Wis.–(BUSINESS WIRE)–Fiserv, Inc. (NASDAQ: FISV), a leading global provider of payments and financial services technology solutions, today announced a new capability designed to optimize how large enterprises using its Carat operating system are able to access, analyze, and utilize their payments data. With a new data-as-a-service (DaaS) capability that enables synching of data through the Snowflake Data Cloud, Carat clients have near-real-time access to their enterprise-wide transaction data, critical intelligence that can help businesses make informed decisions to reduce risk, optimize commerce, and enhance customer experiences.

The new DaaS capability allows businesses to sync reporting and analytics from Carat with the business’s existing data warehouse. Synching via the cloud removes the need for enterprises to build ETL (extract, transform, load) integrations, reducing operational costs and removing the need for manual intervention. Doing so allows a business to access transactional data with speed and accuracy, and empowers them with rich insights that will help strengthen commerce models.

“The introduction of Carat data-as-a-service capabilities will enable large enterprises to leverage Snowflake Secure Data Sharing and its collaboration capabilities to maximize the value they are able to extract from payment data,” said Rinesh Patel, Global Industry GTM Lead, Financial Services at Snowflake. “By enabling seamless and secure data transfer via the cloud, the Carat operating system modernizes how payment data flows to decision makers and can be used to guide business decisions.”

With ready-to-query data, a business can also enhance consumer experiences by integrating real-time payments data into the checkout process. This can enable the business to use data intelligence to strengthen loyalty and rewards programs, improve decisioning for embedded financial services, and augment fraud mitigation.

“We continue to strengthen our commerce ecosystem with meaningful investments that enable our partners to operate with efficiency, earn client trust, and create better experiences for their customers,” said Casey Klyszeiko, Head of Carat and Global eCommerce at Fiserv. “By leveraging data in real time across business functions, our partners are able to innovate at the speed expected in today’s rapidly changing commerce landscape.”

Carat is the unified, simple, global operating system that enables payments anywhere and anytime, optimizes commerce across channels, and delivers embedded finance in ways that create new customer experiences. Learn more at carat.fiserv.com.

About Fiserv

Fiserv, Inc. (NASDAQ: FISV) aspires to move money and information in a way that moves the world. As a global leader in payments and financial technology, the company helps clients achieve best-in-class results through a commitment to innovation and excellence in areas including account processing and digital banking solutions; card issuer processing and network services; payments; e-commerce; merchant acquiring and processing; and the Clover® cloud-based point-of-sale and business management platform. Fiserv is a member of the S&P 500® Index, the FORTUNE® 500, and has been recognized as one of FORTUNE World’s Most Admired Companies® for 11 of the past 14 years and named among the World’s Most Innovative Companies by Fast Company for two consecutive years. Visit fiserv.com and follow on social media for more information and the latest company news.

FISV-G

Media Relations:

Chase Wallace

Director, Communications

Fiserv, Inc.

+1 470-481-2555

[email protected]

Additional Contact:

Ann S. Cave

Vice President, External Communications

Fiserv, Inc.

+1 678-325-9435

[email protected]

KEYWORDS: United States North America Wisconsin

INDUSTRY KEYWORDS: Professional Services Data Management Technology Mobile/Wireless Software Finance Banking

MEDIA:

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Alzamend Neuro Submits IND Application for Phase I/IIA Trial for an Immunotherapy (ALZN002) to Treat Mild to Moderate Dementia of the Alzheimer’s Type

Alzamend Neuro Submits IND Application for Phase I/IIA Trial for an Immunotherapy (ALZN002) to Treat Mild to Moderate Dementia of the Alzheimer’s Type

ATLANTA–(BUSINESS WIRE)–Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar disorder, major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), today announced that it submitted an investigational new drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) for its immunotherapy product candidate ALZN002. The product candidate is designed to treat mild to moderate dementia of the Alzheimer’s type. ALZN002 is a proprietary “active” immunotherapy product, which means it is produced by each patient’s immune system. It consists of autologous dendritic cells (“DCs”) that are activated white blood cells taken from each individual patient so that they can be engineered outside of the body to attack Alzheimer’s-related amyloid-beta proteins. These DCs are pulsed with a novel amyloid-beta peptide (E22W) designed to bolster the ability of the patient’s immune system to combat Alzheimer’s; the goal being to foster tolerance to treatment for safety purposes while stimulating the immune system to reduce the brain’s beta-amyloid protein burden, resulting in reduced Alzheimer’s signs and symptoms. Compared to passive immunization treatment approaches that use foreign blood products (such as monoclonal antibodies), active immunization with ALZN002 is anticipated to offer a more robust and long-lasting effect on the clearance of amyloid. This could provide a safer approach due to its reliance on autologous immune components, using each individual patient’s own white blood cells rather than foreign cells and/or blood products.

The submitted IND supports initial deployment of a clinical trial, ALZN002-01, a first-in-human, randomized, double-blind, placebo-controlled, parallel-group, Phase I/IIA clinical trial. The purpose of this trial will be to assess the safety, tolerability, and efficacy of multiple ascending doses of ALZN002 compared with that of placebo in 20‑30 subjects with mild to moderate dementia of the Alzheimer’s type. Also, the trial will be designed to determine the optimal dosage of ALZN002, allowing for induction of anti-Amyloid-beta antibody responses that can target Alzheimer’s-associated brain proteins while maintaining safety. The primary goal of this initial clinical trial is to determine an appropriate dose of ALZN002 for treatment of patients with Alzheimer’s in a larger Phase IIB efficacy and safety clinical trial (ALZN002-02), which Alzamend expects to initiate within three months of receiving data from the initial trial.

ALZN002 immunotherapy is intended to treat patients diagnosed with Alzheimer’s by inducing the patient’s own antibodies. These are targeted to remove Aβ1‑42 protein, reducing deposition of amyloid plaque in the brain and thereby reducing the progression of disease-associated clinical signs and symptoms. The ALZN002 DC treatment is, by definition, an individual-patient-specific therapy since these autologous DCs are administered to the same patient from whom they were removed. Each patient will undergo leukapheresis, i.e., removal and return to the body of white blood cells. This procedure will isolate each patient’s peripheral blood monocytes from the obtained white blood cells. These are subsequently differentiated outside the body into DCs that are engineered to induce immunogenicity (search and destroy capability) towards amyloid, the protein associated with Alzheimer’s in the patient’s body, but to be otherwise tolerated as natural to the body to avoid adverse side effects.

Multiple pre-clinical studies have been conducted using a transgenic (or genetically modified) mouse model of Alzheimer’s disease at Charles River Laboratories that reported encouraging Alzheimer’s disease-related measurements and neurobehavioral effects, supporting this IND application. Strong evidence of significant ALZN002‑mediated amyloid plaque reductions was observed in mouse disease models. There were no undue adverse findings in a good laboratory practices toxicology study, which consisted of five injections administered over a 90-day period and evaluated for 90 days after the last dose. Histopathology results demonstrated that there were no indication of T-cell infiltration or meningoencephalitis, suggesting that ALZN002 is safe and tolerable. In addition, there were no treatment-related mortalities or reports of adverse effects on clinical observations, body weight parameters, organ weight parameters, clinical pathology parameters, gross pathology observations, or histopathologic observations during the main study or the recovery phase.

“This IND submission represents a key milestone for Alzamend as we continue to advance our proprietary pipeline. There remains a need to develop new therapies that alter the progression of Alzheimer’s and prevent, reverse or slow neurodegeneration and cognitive decline,” said Stephan Jackman, Chief Executive Officer of Alzamend. “We strongly believe that the ALZN002 patient-specific immunotherapeutic vaccine has the potential to achieve these objectives and bring aid to the 6+ million Americans afflicted with this devastating disease. We look forward to providing more details on the timeline following FDA clearance of the IND, if obtained.”

About Alzamend Neuro

Alzamend is an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s, bipolar disorder, MDD and PTSD. Our mission is to rapidly develop and market safe and effective treatments. Our current pipeline consists of two novel therapeutic drug candidates, AL001 – a patented ionic cocrystal technology delivering lithium via a therapeutic combination of lithium, proline and salicylate, and ALZN002 – a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient’s immunological system to combat Alzheimer’s. Both of our product candidates are licensed from the University of South Florida Research Foundation, Inc. pursuant to royalty-bearing exclusive worldwide licenses.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “believes,” “plans,” “anticipates,” “projects,” “estimates,” “expects,” “intends,” “strategy,” “future,” “opportunity,” “may,” “will,” “should,” “could,” “potential,” or similar expressions. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties. Forward-looking statements speak only as of the date they are made, and Alzamend undertakes no obligation to update any of them publicly in light of new information or future events. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. More information, including potential risk factors, that could affect Alzamend’s business and financial results are included in Alzamend’s filings with the U.S. Securities and Exchange Commission. All filings are available at www.sec.gov and on Alzamend’s website at www.Alzamend.com.

Email: [email protected] or call: 1-844-722-6333

KEYWORDS: Georgia United States North America

INDUSTRY KEYWORDS: Mental Health FDA Health Clinical Trials Pharmaceutical Biotechnology

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VBI Vaccines Announces Initiation of Phase 1 Study of Multivalent Coronavirus Vaccine Candidate, VBI-2901

VBI Vaccines Announces Initiation of Phase 1 Study of Multivalent Coronavirus Vaccine Candidate, VBI-2901

  • Initiation of first clinical study of multivalent VBI-2901, designed to increase breadth of protection against COVID-19 and related coronaviruses
  • Preclinical data support broadly reactive immunity of VBI-2901 against a panel of coronavirus variants in mice, which now also includes circulating BA.4 and BA.5
  • The study is expected to enroll approximately 100 adults in Canada and is supported by the Government of Canada
  • Interim data expected mid-year 2023, subject to speed of enrollment

CAMBRIDGE, Mass.–(BUSINESS WIRE)–VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced the initiation of enrollment in the Phase 1 clinical study of VBI-2901, a multivalent enveloped virus-like particle (eVLP) coronavirus vaccine candidate expressing the full-length spike proteins from the SARS-CoV-1 (SARS), SARS-CoV-2 (COVID-19), and MERS-CoV (MERS) viruses.

Jeff Baxter, VBI’s President and CEO commented, “We strive to contribute to the long-term solution in the fight against coronaviruses and remain committed to supporting our public health partners. As we work to develop a vaccine capable of providing broad protection against known, emerging, and as-yet-unknown COVID-19 and coronavirus strains, we believe this study initiation is a meaningful step toward that goal.”

Coronaviruses are enveloped viruses by nature, making them prime targets for VBI’s flexible eVLP technology, which in a Phase 1a/1b study of two monovalent, variant-specific vaccine candidates generated human proof-of-concept data demonstrating the safety, tolerability, and immunogenicity of the eVLP platform against coronaviruses.

David Anderson, Ph.D., VBI’s Chief Scientific Officer added, “We are excited to kick-off the first human study of VBI-2901, a candidate that has consistently elicited a stronger response than our variant-specific candidates against a broad panel of coronavirus variants in mice. Our preclinical panels now include BA.4 and BA.5 as well as the ancestral strain, Delta, Beta, Lambda, Omicron, and pangolin and bat coronaviruses distantly related to circulating human strains. These data seen to date demonstrated that, generally, as the strains became more divergent from the ancestral strain, VBI-2901 elicited a greater increase in antibody responses compared to our other variant-specific COVID-19 vaccine candidates.”

The Phase 1 randomized, open-label study will enroll three cohorts of subjects, randomized 1:1:1, to compare either two intramuscular doses of VBI-2901 at a low- (5µg) or high- (10µg) dose level, or one dose of VBI-2901 at the high-dose level (10µg) in approximately 100 healthy adults age 18-64 who have previously received two or more immunizations with COVID-19 vaccines licensed by Health Canada. Each participant must have received their previous dose of a licensed COVID-19 vaccine at least six months prior to study enrollment.

This study is supported by funding from the Government of Canada’s Innovation, Science and Economic Development (ISED) through the Strategic Innovation Fund.

About VBI’s Coronavirus Vaccine Program: VBI-2900

VBI-2900 consists of three enveloped virus-like particle (eVLP) vaccine candidates: (1) VBI-2901, a multivalent coronavirus vaccine expressing the SARS-CoV-2, SARS-CoV, and MERS-CoV spike proteins, (2) VBI-2902, a monovalent COVID-19 vaccine expressing a modified prefusion form of the SARS-CoV-2 ancestral spike protein, and (3) VBI-2905, a monovalent COVID-19 vaccine expressing a modified prefusion form of the spike protein from the Beta variant (also known as B.1.351).

The vaccine program has been developed through collaborations with the National Research Council of Canada (NRC), the Coalition for Epidemic Preparedness Innovations (CEPI), and the Government of Canada, through their Strategic Innovation Fund.

About VBI Vaccines Inc.

VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel.

For more information, visit www.vbivaccines.com.

Cautionary Statement on Forward-looking Information

Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). The Company cautions that such statements involve risks and uncertainties that may materially affect the Company’s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the impact of general economic, industry or political conditions in the United States or internationally; the impact of the ongoing COVID-19 pandemic on our clinical studies, manufacturing, business plan, and the global economy; the ability to successfully manufacture and commercialize PreHevbrio/PreHevbri; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of pipeline candidates and the commercialization of PreHevbrio/PreHevbri; the ability to obtain appropriate or necessary regulatory approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company’s products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company’s filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 7, 2022, and filed with the Canadian security authorities at sedar.com on March 7, 2022, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.

VBI:

Nicole Anderson

Director, Corporate Communications & IR

Phone: (617) 830-3031 x124

Email: [email protected]

KEYWORDS: Massachusetts United States North America Canada

INDUSTRY KEYWORDS: Biotechnology FDA Other Health Health Pharmaceutical Oncology Research Infectious Diseases Science COVID-19 Clinical Trials

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Horizon Therapeutics plc Completes Enrollment for Phase 4 Trial of TEPEZZA® (teprotumumab-trbw) in Adults with Chronic/Low Clinical Activity Score (CAS) Thyroid Eye Disease (TED)

Horizon Therapeutics plc Completes Enrollment for Phase 4 Trial of TEPEZZA® (teprotumumab-trbw) in Adults with Chronic/Low Clinical Activity Score (CAS) Thyroid Eye Disease (TED)

— Topline results expected in second quarter of 2023 —

DUBLIN–(BUSINESS WIRE)–
Horizon Therapeutics plc (Nasdaq: HZNP) announced that it has completed enrollment of its Phase 4 clinical trial (NCT04583735) evaluating TEPEZZA for the treatment of Thyroid Eye Disease (TED) in patients with a low Clinical Activity Score (CAS), also known as the TEPEZZA Chronic TED trial. CAS is a tool designed to evaluate inflammatory signs and symptoms that are often associated with TED.1 Topline results are expected in the second quarter of 2023.

TED is a serious, progressive and potentially vision-threatening rare autoimmune disease. Symptoms of TED may include dry eyes and grittiness; redness, swelling and excessive tearing; eyelid retraction; proptosis (eye bulging); pressure and/or pain behind the eyes; and diplopia (double vision). TEPEZZA was approved by the U.S. Food and Drug Administration (FDA) in January 2020 as the first and only medicine for Thyroid Eye Disease.

“I see the severe impact of Thyroid Eye Disease daily in patients with all levels of inflammation, and it disrupts not only their ability to function, but also their enjoyment of life,” said Raymond Douglas, M.D., Ph.D., trial investigator and director of the Orbital and Thyroid Eye Disease Program, Cedars-Sinai Medical Center. “The TEPEZZA pivotal trial data showed significant improvement in some of the most debilitating symptoms of TED in people with more inflammatory disease. Since then, we’ve seen real-world experience and published case reports that have shown benefits of TEPEZZA treatment in patients with low Clinical Activity Scores – this trial will help us better illustrate the use of TEPEZZA in that population.”

This randomized, double-masked, placebo-controlled, parallel-group, multicenter trial is evaluating the efficacy, safety and tolerability of TEPEZZA compared to placebo in treating TED patients with a low CAS (1 or less at the screening and baseline visits), two to 10 years since eye symptom onset, and non-worsening proptosis for at least a year. Adult participants who met the trial eligibility criteria were randomized in a 2:1 ratio to receive an infusion of either TEPEZZA or placebo, 10 mg/kg for the first infusion and 20 mg/kg for the remaining seven infusions, once every three weeks, for a total of eight infusions.

The primary efficacy endpoint is change from baseline at Week 24 in proptosis in the study eye. The trial will also assess proptosis responder rate, diplopia responder rate, change in orbital pain, change in muscle volume and change in the Graves’ Ophthalmopathy Quality of Life (GO-QoL) questionnaire appearance and visual functioning subscales. Proptosis nonresponders who complete the treatment period may choose to enter an open-label extension period where they will receive eight infusions of TEPEZZA.

“We are grateful to the Thyroid Eye Disease patient community and all of our principal investigators for their partnership and participation in this trial,” said Elizabeth H.Z. Thompson, Ph.D., executive vice president, research and development, Horizon. “We frequently hear people with Thyroid Eye Disease stress how the painful, potentially vision-threatening symptoms continue throughout the patient journey. As our understanding of Thyroid Eye Disease and the patient experience continues to evolve, studies like this are critical to ensuring the needs of all patients are being met.”

About Thyroid Eye Disease (TED)

TED is a serious, progressive and potentially vision-threatening rare autoimmune disease.1 It often occurs in people living with Graves’ disease, but is a distinct disease that is caused by autoantibodies activating an IGF-1R-mediated signaling complex on cells within the retro-orbital space.2,3 This leads to a cascade of negative effects, which may cause long-term, irreversible damage, including blindness.4,5 Early signs and symptoms of TED may include dry eyes and grittiness; redness, swelling and excessive tearing; eyelid retraction; proptosis; pressure and/or pain behind the eyes; and diplopia.

About TEPEZZA

INDICATION

TEPEZZA is indicated for the treatment of Thyroid Eye Disease.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Infusion Reactions: TEPEZZA may cause infusion reactions. Infusion reactions have been reported in approximately 4% of patients treated with TEPEZZA. Reported infusion reactions have usually been mild or moderate in severity. Signs and symptoms may include transient increases in blood pressure, feeling hot, tachycardia, dyspnea, headache and muscular pain. Infusion reactions may occur during an infusion or within 1.5 hours after an infusion. In patients who experience an infusion reaction, consideration should be given to premedicating with an antihistamine, antipyretic, or corticosteroid and/or administering all subsequent infusions at a slower infusion rate.

Preexisting Inflammatory Bowel Disease: TEPEZZA may cause an exacerbation of preexisting inflammatory bowel disease (IBD). Monitor patients with IBD for flare of disease. If IBD exacerbation is suspected, consider discontinuation of TEPEZZA.

Hyperglycemia: Increased blood glucose or hyperglycemia may occur in patients treated with TEPEZZA. In clinical trials, 10% of patients (two-thirds of whom had preexisting diabetes or impaired glucose tolerance) experienced hyperglycemia. Hyperglycemic events should be managed with medications for glycemic control, if necessary. Monitor patients for elevated blood glucose and symptoms of hyperglycemia while on treatment with TEPEZZA. Patients with preexisting diabetes should be under appropriate glycemic control before receiving TEPEZZA.

Adverse Reactions

The most common adverse reactions (incidence ≥5% and greater than placebo) are muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia, hearing impairment, dysgeusia, headache, dry skin, and menstrual disorders.

Please see Full Prescribing Information or visit TEPEZZAhcp.comfor more information.

About Horizon

Horizon is a global biotechnology company focused on the discovery, development and commercialization of medicines that address critical needs for people impacted by rare, autoimmune and severe inflammatory diseases. Our pipeline is purposeful: We apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, visit www.horizontherapeutics.com and follow us on Twitter, LinkedIn, Instagram and Facebook.

Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements related to the potential benefits of TEPEZZA; the anticipated timing of results from the Phase 4 clinical trial; the design of clinical trials and other statements that are not historical facts. These forward-looking statements are based on Horizon’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to clinical trials, including the fact that prior results may not predict future clinical trial outcomes; impacts of the COVID-19 pandemic and actions taken to slow its spread, including potential delays in clinical trials; regulatory obligations and oversight, including any changes in the legal and regulatory environment in which Horizon operates and those risks detailed from time-to-time under the caption “Risk Factors” and elsewhere in Horizon’s filings and reports with the SEC. Horizon undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information.

References

  1. Barrio-Barrio J, Sabater AL, Bonet-Farriol E, Velazquez-Villoria A, Galofre JC. Graves’ Ophthalmopathy: VISA versus EUGOGO Classification, Assessment, and Management. Journal of Ophthalmology. 2015;2015:1-16.
  2. Weightman DR, et al. Autoantibodies to IGF-1 Binding Sites in Thyroid Associated Ophthalmopathy. Autoimmunity. 1993;16(4):251–257.
  3. Pritchard J, et al. Immunoglobulin Activation of T Cell Chemoattractant Expression in Fibroblasts from Patients with Graves’ Disease Is Mediated Through the Insulin-Like Growth Factor 1 Receptor Pathway. J Immunol. 2003;170:6348-6354.
  4. McKeag D, et al. Clinical features of dysthyroid optic neuropathy: a European Group on Graves’ Orbitopathy (EUGOGO) survey. Br J Ophthalmol. 2007;91:455-458.
  5. Bartalena L, Kahaly GJ, Baldeschi L, et al. The 2021 European Group on Graves’ Orbitopathy (EUGOGO) Clinical Practice Guidelines for the Medical Management of Graves’ Orbitopathy. Eur J Endocrinol. 2021;185(4):G43-G67. Published 2021 Aug 27.

Investor Relations:

Tina Ventura

Senior Vice President, Chief Investor Relations Officer

[email protected]

Erin Linnihan

Executive Director, Investor Relations

[email protected]

U.S. Media:

Rachel Vann

Senior Director, Product Communications

[email protected]

Maggie Fairchild

Associate Director, Product Communications

[email protected]

Ireland Media:

Gordon MRM

Ray Gordon

[email protected]

KEYWORDS: New York Europe Ireland United States North America

INDUSTRY KEYWORDS: Other Health Health Pharmaceutical Optical Clinical Trials

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Knightscope Robot Roadshow is Coming to Huntley, Illinois

Knightscope Robot Roadshow is Coming to Huntley, Illinois

Public Safety Innovator Continues to Drive Sales through Creative Marketing Events

MOUNTAIN VIEW, Calif.–(BUSINESS WIRE)–Knightscope, Inc. [Nasdaq: KSCP], a developer of advanced physical security technologies focused on enhancing U.S. security operations, today announced its Robot Roadshow – an engaging experiential event used to grab attention fast, forge direct connections with potential clients, and strike up conversations in a compelling fashion – will land in the suburbs of Chicago at Huntley Village Green, 13304 Village Green Dr, Huntley, IL 60047, on 3 October 2022 from 10:00am to 2:00pm CT.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220929005309/en/

Knightscope Robot Roadshow is Coming to Huntley, Illinois (Photo: Business Wire)

Knightscope Robot Roadshow is Coming to Huntley, Illinois (Photo: Business Wire)

The Robot Roadshow has made 60 landings in 23 states and Washington, D.C. to date. Knightscope’s crime-fighting robots tour the U.S. in a space-age, NASA-like “pod” allowing attendees to experience all the technology that is enabling these Autonomous Security Robots (ASRs) to help make sites safer today from Hawaii to Texas to North Carolina. A short video of a past event hosted by the Los Angeles Police Department may be viewed here.

The Huntley Roadshow landing will be guided by Knightscope experts both virtually and in person. Visitors will be able to interact directly with each of the ASRs and see the Knightscope Security Operations Center (KSOC) user interface in action. Clients, investors and the media are all welcome to attend to learn more about Knightscope.

There is no charge to participate in, or visit, the Roadshow and available slots fill up fast, so appointments are recommended. Book your Pod visit here.

About Knightscope

Knightscope is an advanced security technology company based in Silicon Valley that builds fully autonomous security robots that deter, detect and report. Knightscope’s long-term ambition is to make the United States of America the safest country in the world. Learn more about us at www.knightscope.com. Follow Knightscope on Facebook, Twitter, LinkedIn and Instagram.

Forward Looking Statements

This press release may contain ”forward-looking statements” about Knightscope’s future expectations, plans, outlook, projections and prospects. Such forward-looking statements can be identified by the use of words such as ”should,” ”may,” ”intends,” ”anticipates,” ”believes,” “estimates,” “projects,” “forecasts,” “expects,” “plans,” ”proposes” and similar expressions. Although Knightscope believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2021. Forward-looking statements speak only as of the date of the document in which they are contained, and Knightscope does not undertake any duty to update any forward-looking statements except as may be required by law.

Public Relations:

Stacy Stephens

Knightscope, Inc.

(650) 924-1025

Corporate Communications:

IBN (InvestorBrandNetwork)

Los Angeles, California

www.InvestorBrandNetwork.com

310.299.1717 Office

[email protected]

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Technology Mobile/Wireless Other Technology Drones Software Networks Hardware Data Management Artificial Intelligence

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Knightscope Robot Roadshow is Coming to Huntley, Illinois (Photo: Business Wire)